BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 2950032 · Received February 6, 2013

    Report

    Report Number
    2950032
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT FELL APART INSIDE PATIENT WHILE BEING USED. ALL PARTS RETRIEVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50079 ENSEAL TRIO CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, INC. * J4CJ7J

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR NO OTHER THERAPIES